DoP proposes to oversee drug regulator

As the government plans a major overhaul of the country’s drug authority, the Department of Pharmaceuticals (DoP) has proposed to oversee Central Drugs Standard Control Organisation (CDSCO) to be transferred to it.

Concerns had been raised at the highest levels of the government over the ability of the regulatory framework to keep up with the demands of industry and scientists, triggering the move to revamp the drug authority,
according to media report.

According to the order accessed by ET, A committe had been constituted by the Cabinet secretary for reforming the drug regulatory system under the chairmanship of Sh. Rajesh Bhushan who will take over as health secretary from the present health secretary Preeti Sudan after three months. The committee will held a meeting on Friday.

In view od DoP, since it deals with the pharma industry the CSDCO should come under its ambit. According to the DoP, the same will cut down unnecessary time delay in giving approval to a drug or a vaccine.

According to the sources, “There are multiple agencies involved in the regulatory framework for a drug/vaccine approval. The DoP also has the National Pharmaceutical Pricing Authority under it. “
“The DoP has suggested that CDSCO be shifted under its charge.”

Source: ET


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